The report, released in early April 2014, is relevant to stakeholders in a whole host of fields, from telemedicine to new horizons in healthcare self-help apps.
On our Foley Hoag website, see our full review of the new 2014 consensus report: go to our full website here. We also provide the text as a 4-page PDF.
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On April 7, 2014, the Food and Drug
Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework”
(the “Report”). The Report was mandated by section 618 of the
Food and Drug
Administration Safety and Innovation Act (FDASIA), which required the FDA
consult with the Office of the National Coordinator for Health Information
Technology (ONC) and the Federal Communications Commission (FCC). These three
agencies were tasked to work together to prepare a report containing “a
proposed strategy and recommendations on an appropriate, risk-based regulatory framework
pertaining to health IT [information technology], including mobile medical
applications, that promotes innovation, protects patient safety, and avoids
regulatory duplication.” The Report emerged in substantial part from meetings of the FDASIA workgroup.
The 32-page Report is open to
public comment until July 7, 2014 via a public docket (FDA-2014-N-0339).
Comments may be submitted through www.regulations.gov.
The agencies seek public comments on whether the Report addresses the
appropriate focus areas, and whether the proposed next steps are appropriate.
The Report itself also poses questions for the public throughout, seeking input
on specific recommendations. Additionally, on May 13-15 FDA will hold a publicworkshop to discuss the following topics raised in the Report: use of quality
management principles, standards and best practices, conformity assessment
tools, creating an environment of learning and continual improvement, and
clinical decision support (CDS) software.
As additional context, both British and European authorities
have released policy documents on medical software regulation and mobile health
regulation, respectively.
Attached is the summary of the
Report with a focus on provisions that affect two key areas: electronic health records (EHR) and CDS software.
Summary
of the Report
• Division of Regulation by Functionality
• Framework for the Oversight of Health Management Health IT
• Clarity Regarding the Regulation of CDS
• Continued Agency Interactions
Continued at: our FDASIA Health IT website here.
• Framework for the Oversight of Health Management Health IT
• Clarity Regarding the Regulation of CDS
• Continued Agency Interactions
Continued at: our FDASIA Health IT website here.
